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Description:Supplier Quality EngineerThe Supplier Quality Engineer drives quality improvements through the supply chain, addressing incoming yield and on time delivery by addressing supplier qualification & development, supplier corrective actions, component engineering and reliability improvement. This candidate works with external suppliers, company R&D and Manufacturing to address supplier-related quality concerns and implement cost-saving measures. The Supplier Quality Engineer provides applicable regulatory compliance support for compliance to Quality System. For more information on how to apply, please email [link removed] [email removed] or call Zahra at (408) 626-8300 * 310. Thanks! Goals: ? Support and improve device reliability by driving quality throughout the entire supply chain. ? Increase first-pass yield and incoming acceptance rate ? Improve approach to supplier quality during the R&D phase. ? Monitor, Analyze and Report on Supplier Performance Duties and Responsibilities ? Develop and implement Supplier systems to support GMP/ISO requirements , providing guidance on standards, process control, quality system procedures and other requirements to purchasing team and external suppliers ? Reviews trends in rejections at incoming ? Works with the buyer and materials management to determine appropriate risk mitigation activities ? Qualifies, communicates with, audits and certifies subcontractors ? Coordinate component verification and qualification activities for new materials and components Conduct supplier reviews for new product including coordination of critical measures, gauging systems and evaluation of process stability and capability ? Coordinate with Purchasing and QA for initial supplier and component approval ? Conduct Supplier Audits, evaluate supplier performance, and determine documentation and certification requirements. ? Document and train QA inspectors to follow the appropriate inspection procedures ? Develop and document statistically sound sampling plans for incoming materials ? Develop systems to assure product and material specification conformance ? Evaluate, procure and install the required equipment to measure and evaluate incoming material Develop and maintain a corrective action loop to include raw materials, work in process and finish product ? Perform validations to implement new tests and/or test equipment ? Assist with process/tooling changes and Supplier Change Management ? Continually update and make improvements to the test methods, inspection forms and related documentation used to evaluate product functionality and quality ? Monitor the "dock to stock" program ? Provide hands-on technical support to Receiving Inspection and for statistically valid sampling plans and acceptance criteria ? Support manufacturing processes as a technical resource for process improvements projects such as alternative measurement/testing methodologies, ? Other duties as defined Education and/or Experience ? BS in Engineering or Life Science ? Knowledge of QSR/ISO requirements ? CQE, CRE or CQA certification, preferred ? Knowledge of GD&T, preferred ? Five or more years experience in a Quality Assurance position ? Familiarity with 3D CAD software, e.g., SolidWorks, desired ? Experience with wire EDM, Plastic injection molding, metallurgy a plus ? Experience in leading or participating in QSR/ISO/Quality System compliance audits, preferred ? Excellent oral and written communications with the ability to interface professionally at all the levels of management ? Excellent interpersonal and organizational skills ? Able to accomplish multiple assignments simultaneously ? Able to work effectively in teams or as a leader ? Knowledge and experience in process and product validation Misc ? Occasional extensive travel to suppliers as required. Approximately 30% travel required for this position
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